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Emerphed

These highlights do not include all the information needed to use EMERPHED safely and effectively. See full prescribing information for EMERPHED.EMERPHED (ephedrine sulfate) injection, for intravenous use. Initial U.S. Approval: 2016

Approved
Approval ID

e1323592-dc57-4c9d-b84d-442648a7b114

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 30, 2022

Manufacturers
FDA

Nexus Pharamaceuticals Inc.

DUNS: 620714787

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ephedrine Sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code14789-250
Application NumberNDA213407
Product Classification
M
Marketing Category
C73594
G
Generic Name
Ephedrine Sulfate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 30, 2022
FDA Product Classification

INGREDIENTS (3)

WaterInactive
Code: 059QF0KO0R
Classification: IACT
Ephedrine SulfateActive
Quantity: 5 mg in 1 mL
Code: U6X61U5ZEG
Classification: ACTIB
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT

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Emerphed - FDA Drug Approval Details